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Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis

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ClinicalTrials.gov Identifier: NCT01359995
Recruitment Status : Unknown
Verified May 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 25, 2011
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.

Condition or disease
Cytomegalovirus Endotheliitis

Detailed Description:

In this study, we recruit 7 immunocompetent patients with unexplained graft failures, which mimicked herpetic anterior uveitis and graft rejection initially, were diagnosed as CMV endotheliitis after aqueous tapping for CMV polymerase chain reaction (PCR). Topical ganciclovir was used to control and prevent the reactivation of CMV without systemic application and their clinical courses were presented after this treatment modality.

The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.


Study Type : Observational
Estimated Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. clinical courses before and after topical ganciclovir in patients with CMV endotheliitis [ Time Frame: participants will be monitored after receiving topical ganciclovir,an expected average of 1 year ]
    evaluations including aqueous PCR for CMV, endothelium cell density on confocal microscopy,degree of anterior chamber inflammation..



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
4 men, 3 women, aged 40-90 years old
Criteria

Inclusion Criteria:

  • immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty

Exclusion Criteria:

  • patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359995


Contacts
Contact: I-Jong Wang, M.D. PhD 886-23123456 ext 65729 ijong@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: I-Jong Wang, M.D. PhD    886-23123456 ext 65729    ijong@ms8.hinet.net   
Principal Investigator: I-Jong Wang, M.D. PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: I-Jong Wang, M.D. PhD National Taiwan University Hospital